Nuvex Biotech provides specialized pre-GMP formulation development for pharmaceutical innovators. We partner with startups and small pharma companies to solve complex drug-delivery challenges.

What We Do

We bridge the gap between discovery and clinical readiness. Our team works across three core areas:

OTIC
First-in-class programs for necrotizing otitis externa and sensorineural hearing loss, plus 505(b)(2) specialty generics. We specialize in high-concentration antibiotics, biologics stability for intratympanic delivery, and viscosity optimization for canal retention.

Ophthalmics
Preservative-free multidose systems, post-surgical care formulations (anti-infectives, anti-inflammatories, regeneration therapies), and 505(b)(2) specialty generics. Expertise in in-situ gelling, intracameral injections, and combination products.

Topicals
Deep specialization in compromised skin—geriatric, pediatric, chronic wounds, and pain management. Capabilities include penetration-controlled formulations, sensory-optimized rheology, bioadhesive hydrogels, sustained-release systems, and advanced delivery platforms (nanoencapsulation, polymeric carriers).

Across all areas, we deliver:

Formulation troubleshooting and incompatibility resolution
Stability design and optimization
Scale-up strategy and process development
Decision-ready and CMC-ready data packages for IND submissions

Our Approach

Early-stage decisions determine clinical outcomes. We structure our work to deliver clarity - so you know whether to advance, adjust, or pause before committing to GMP manufacturing. We move fast and iteratively, because we understand the pace young companies need to maintain. No unnecessary experiments. No vague timelines. Just reproducible science and clear communication.

For pharmaceutical innovators developing complex therapies, Nuvex delivers the specialized pre-GMP partnership that bridges concept to clinic. Open to conversations with founders, R&D leaders, and technical teams

Nuvex Biotech

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